Kornimate/medical-research-clean huggingface dataset:
a study of combination nivolumab and ipilimumab retreatment in patients with advanced renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the purpose of the study is to assess the effectiveness of re-induction with nivolumab combined with ipilimumab.


Eligibility criteria:
inclusion criteria: -participants and target disease characteristics- - * confirmed disease progression by recist 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab * progress of maintenance treatment of nivolumab by recist. pathology report must be submitted for embedded tissue block or tumor tissue. age and reproduction sexually active males with wocbp must agree to instructions for contraception and fetal protection. wocbp need to use contraception throughout the study and for 5 months post treatment. exclusion criteria autoimmune disease statement * active central nervous system metastases * participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll. * any major surgery 28 days before 1st treatment concomitant therapy * participants that have received a live vaccine within 30 days of treatment. * use of investigational agent or device with in 28 days before first dosage study treatment. physical and laboratory test findings allergies and adverse drug reaction age and reproduction
dietary impact on intestinal sulfate metabolism

Conditions: Healthy Nutrition

Summary: this is a 5-week crossover pilot study of 15 highly motivated healthy volunteers who will consume two 7-day intervention diets: 1) a diet low in sulfur-containing amino acids (low-s diet), emphasizing plant-based foods and fat sources; and 2) a diet high in sulfur-containing amino acids (high-s diet), emphasizing animal protein and fat sources. a 14-day washout period will follow each intervention, in which participants will eat their typical diets.


Eligibility criteria:
inclusion criteria: * provide informed consent * ambulatory and community dwelling * able and willing to comply with the study schedule and procedures * 18 - 80 years of age * bmi between 18.5 - 40.0 kg/m2 * omnivorous or willing to consume animal products through duration of study exclusion criteria: * antibiotic use within 3 months * planned antibiotic therapy within the period of the study, e.g., perioperative antibiotics. * use of sulfonamides or sulfasalazine, as these sulfur-containing medications may confound results * use of 5-aminosalicylates (5-asa), as they are known to inhibit sulfidogenesis * history of anaphylactic food allergies, e.g., peanuts, seafood. * food intolerances and allergies, including gluten sensitivity, lactose intolerance, and intolerance of high fiber dietary content. * strict vegan eating practices, with refusal to consume animal products. * planned use of oral probiotics while on study. * serious, concomitant illness that, in the opinion of the investigator, would interfere with evaluation of safety or efficacy, or put the participant at risk of harm from study participation. * significant alcohol use, defined as \> 20 g/day in females and \> 30 g/day in males for a period of 3 months within one year prior to screening. * underlying chronic gastrointestinal disease that can cause diarrhea, including short bowel syndrome, irritable bowel syndrome, malabsorption, and celiac disease. * history of partial or complete colectomy. * history of malabsorptive bariatric surgery. * currently participating in another clinical study. * legally incompetent and unable to understand the study's purpose, significance and consequences, and to make decisions accordingly.

Keywords: animal-based plant-based microbiome hydrogen sulfide ulcerative colitis
noa-12: bibf1120 and r-rt in glioblastoma

Conditions: Glioblastoma Multiforme

Summary: patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. in the phase i part the minimal tolerated dose (mtd)of bibf 1120 in combination with radiotherapy will be investigated. subjects in phase ii will be randomised to receive reirradiation alone or reirradiation + 2 x mtd bibf1120.


Eligibility criteria:
inclusion criteria: * male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence * diagnosis of glioblastoma must be proven histologically and progress must be documented by mri. mri images must not be older than 2 weeks before first dosing/start of rt * not more than two prior therapy regimens including one or two resections, one or two chemotherapies (one temozolomide containing concomitant to radiotherapy) and one radiotherapy (rt) for the brain tumour * previous irradiation therapy of the primary tumour with a maximal dose of 60 gy; at least 8 months since the end of preirradiation * candidate for reirradiation with recurrent tumour visible on mrit1 (gd) and with the largest diameter measuring 1 cm to 5 cm * informed consent * age ≥ 18 years, smoking or non-smoking, of any ethnic origin * karnofsky performance index (kpi) ≥ 60% * neutrophile counts \> 1500/μl / platelet counts \> 80.000/μl /haemoglobin \> 10 g/dl / serum creatinine \< 1.5-fold upper normal range / bilirubin, ast or alt \< 2,5-fold upper normal range unless attributed to anticonvulsants / alkaline phosphatase \< 2,5-fold upper normal range * adequate contraception * if on steroids, stable or decreasing treatment with steroids within 5 days before treatment start exclusion criteria: * more than one rt of brain, prior first radiotherapy with more than 60 gy * cumulative total dose on the optical chiasm \>54 gy for 2 gy/fraction, α/β=2 * prior treatment with bevacizumab, iodine seeds and/or brachytherapy * unable to undergo mri * past medical history of diseases with poor prognosis according to the judgement of the investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation * hiv or hepatitis infection * pregnancy or breast feeding * treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion * known coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (nyha class iii - iv)
tap block vs spinal orphine for postoperative caesarean section analgetics

Conditions: Post Operative Pain

Summary: the goal of this randomized controlled trial is to compare the effect of tap block vs spinal morphine for post caesarean section analgesics. the main questions it aims to answer are: * which post op analgesic method works better for patients who underwent caesarean section * the number of additional opioid needed


Eligibility criteria:
inclusion criteria: * indicated for caesarean section as assessed by obstetricians * asa ii * consented to be included in the study exclusion criteria: * allergy history * spinal converted to general anesthesia
management of skin and soft tissue abscesses in pediatric patients after incision and drainage

Conditions: Abscess

Summary: the purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. the purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral tmp/smx) versus non-antibiotic treatment after incision and drainage.

this study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (tmp/smx) or placebo after incision and drainage. every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). equal numbers of subjects were randomized at the outset to both study groups. randomization, also done by our investigational pharmacy department, was done in blocks of 20. patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. they were not charged for this visit, and their valet parking was validated. if an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion. primary outcome: 1. abscess resolution by parental report 7-10 days after incision and drainage secondary outcomes: 1. admission to the hospital because of worsening infection 2. receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)

Eligibility criteria:
inclusion criteria: 1.) abscess \ 90 days and \< 18 years 3.) abscess on the trunk, scalp, extremities, or axillae exclusion criteria: 1. multiple abscesses 2. abscess located on the hands, face, or perineum 3. abscess as a result of a bite wound 4. immunocompromised patient - i.e., diabetes, sickle cell, chronic steroid therapy (\> 10 days), etc. 5. previously failed 48 hours or greater therapy on any antibiotic regimen 6.) drug allergy to tmp/smx 7.) fever \> or = 102.2 degrees fahrenheit in the previous 24 hours 8.) systemic symptoms on presentation - i.e., nausea , vomiting, persistent tachycardia, hypotension, diaphoresis, etc. 9.) signs /symptoms of another infection or illness - i.e., influenza, croup, etc.

Keywords: abscess abscesses in the pediatric emergency population
fatigue in breast cancer survivors

Conditions: Breast Cancer; Cancer Survivor; Fatigue; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: gathering information over time from blood samples and measurements of activity, sleep, mood, and cognition may help doctors learn more about fatigue in breast cancer survivors and plan the best treatment. purpose: this clinical trial is studying fatigue in breast cancer survivors.

objectives: * to investigate the relationship between fatigue severity; protein biomarkers; and measures of activity, sleep, mood, and cognition in breast cancer survivors. * to identify and quantify serum biomarkers and underlying biological pathways unique to cancer-related fatigue syndrome in these survivors. * to map changes over time in order to explore the inter-relationships between these variables. outline: participants undergo fatigue assessment by the diagnostic interview for cancer related fatigue and the fact-fatigue questionnaire; psychological symptoms assessment by the structured clinical interview for dsm-iv, hospital anxiety and depression scale, and the insomnia severity index questionnaires; and quality of life assessment by the eortc-qlqc30 and eortc-qlq-br23 questionnaires twice approximately 3 months apart. participants also undergo activity level, circadian rhythm, and sleep measurements by the micro-mini® motionlogger actigraphy and measurement of cognitive disturbances by the cantabeclipse™ technology. participants undergo blood sample collection for protein analysis by 2d gel electrophoresis and mass spectrometry.

Eligibility criteria:
disease characteristics: * disease-free breast cancer survivors between 3 months and 2 years after completion of primary treatment * recruited from the nurse-led breast cancer follow-up clinic at st george's hospital patient characteristics: * sufficient english language skills * no significant cognitive impairment * no concurrent severe combined immunodeficiency disease prior concurrent therapy: * see disease characteristics

Keywords: psychosocial effects of cancer and its treatment fatigue cancer survivor breast cancer
phoenix post-approval registry - using the phoenix atherectomy systems

Conditions: Peripheral Arterial Disease; Claudication; Critical Limb Ischemia

Summary: the phoenix post-approval registry is a prospective, multi-center, single arm registry sponsored by volcano corporation to evaluate the short and long term performance and clinical outcomes of the phoenix atherectomy system.

the phoenix post-approval registry is an prospective, multi-center, single arm registry, sponsored by volcano corporation, to evaluate the short and long term performance and clinical outcomes of the phoenix atherectomy system. the study includes consecutive patients treated with the phoenix atherectomy system in a post-market (commercial device use) setting. patients will be followed under real-world conditions for up to 12 months after the index procedure. all patients with a planned endovascular revascularization procedure receiving treatment with the phoenix atherectomy system as all or part of their pad treatment strategy may be included. written informed consent must be obtained from each patient prior to enrollment in the study. enrolled patients will undergo pad treatment that includes phoenix atherectomy, according to institutional or local standard of care. data collection will include medical record review of procedures performed according to standard of care.

Eligibility criteria:
inclusion criteria: 1. the patient is ≥18 years of age. 2. patient understands the research nature of the study and is willing and capable of providing written informed consent. 3. scheduled for and receives treatment with the phoenix atherectomy system as all or part of their pad treatment. 4. meets phoenix atherectomy system catheter instruction for use (ifu) criteria. exclusion criteria: * patients who have any of the following exclusion criteria are not eligible for the study: 1. patients unwilling or unable to comply with the protocol including 12-month follow-up for patients with cli at baseline. 2. patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
simvastatin around immediate implant

Conditions: Immediate Implant Placement; Bone Regeneration; Alveolar Bone Resorption

Summary: the study evaluated the effect of local application of simvastatin around immediate implant on the amount of gap fill, ridge dimensional alterations and bone density in humans.


Eligibility criteria:
inclusion criteria: * patients between 20 and 50 years old * requiring the extraction of 2 non-restorable maxillary canine or premolar on each side of the arch * following extraction, the crestal bone had to be located 3 mm apical to the free gingival margin * at least 3 mm of bone beyond the root apex was required to guarantee implant primary stability exclusion criteria: * unstable systemic diseases precluding surgical procedures * compromised general health conditions that would impair bone healing including present history of bone irradiation, patient on bisphosphonates therapy, antitumor chemotherapy * pregnancy * compromised healing conditions e.g. uncontrolled diabetes mellitus

Keywords: simvastatin immediate implant placement gap distance ridge dimension alteration cone beam computed tomopgraphy
study of osi-211 vs. topotecan in patients with relapsed epithelial ovarian cancer

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to estimate the efficacy and safety of osi-211 and topotecan in patients with relapsed epithelial ovarian cancer.


Eligibility criteria:
inclusion criteria: * confirmed relapsed ovarian cancer. * measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral ct scan). * one or two prior regimens of chemotherapy. at least one regimen must have contained cisplatin or carboplatin. * at least three weeks since prior chemotherapy and recovery from any related toxicities. * at least four weeks since prior radiotherapy and recovery from any related toxicities.

Keywords: ovarian cancer
prospective, randomized trial of ticagrelor versus prasugrel in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome (ACS)

Summary: aim of the randomized, open-label, multicenter isar-react 5 trial is to assess whether ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned invasive strategy in terms of clinical outcomes.


Eligibility criteria:
major inclusion criteria: hospitalization for an acute coronary syndrome (st-segment elevation myocardial infarction, non-st-segment elevation myocardial infarction or unstable angina pectoris) with planned invasive strategy major exclusion criteria: 1. intolerance of or allergy to ticagrelor or prasugrel 2. history of any stroke, transient ischemic attack or intracranial bleeding 3. known intracranial neoplasm, intracranial arteriovenous malformation or intracranial aneurysm 4. active bleeding, clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding 5. fibrin-specific fibrinolytic therapy less than 24 h before randomization, non-fibrin-specific fibrinolytic therapy less than 48 h before randomization 6. known platelet count \< 100.000/μl at the time of screening 7. known anemia (hemoglobin \<10 g/dl) at the time of screening 8. oral anticoagulation that cannot be safely discontinued for the duration of the study 9. inr known to be greater than 1.5 at the time of screening 10. chronic renal insufficiency requiring dialysis 11. moderate or severe hepatic dysfunction (child pugh b or c) 12. increased risk of bradycardia events (sick sinus, av block grade ii or iii, bradycardia-induced syncope) 13. index event is an acute complication (\< 30 days) of pci 14. concomitant medical illness that in the opinion of the investigator is associated with a life expectancy \< 1 year 15. concomitant oral or i.v. therapy with strong cyp3a inhibitors (e.g. ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice \> 1 l/d), cyp3a substrates with narrow therapeutic indices (e.g. cyclosporine, quinidine), or strong cyp3a inducers (e.g. rifampin/rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital ) that cannot be safely discontinued 16. ≥1 doses of ticagrelor or prasugrel within 5 days before randomisation 17. no written informed consent 18. participation in another investigational drug study 19. previous enrolment in this study 20. for women of childbearing potential no negative pregnancy test and no agree to use reliable method of birth control during the study 21. pregnancy, giving birth within the last 90 days, or lactation 22. inability to cooperate with protocol requirements

Keywords: ticagrelor prasugrel acute coronary syndrome percutaneous coronary intervention
effects of roflumilast on subclinical atherosclerosis in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease and Allied Conditions

Summary: chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory process. systemic inflammation is hypothesized to maintain cardiovascular morbidity and mortality in copd. early changes of vascular integrity can be detected via markers of subclinical atherosclerosis. selective inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option in copd with beneficial impact on lung function and exacerbation rate. moreover, an anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data. the aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of systemic inflammation in the peripheral circulation of patients with stable chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * over 40 years of age * smoking history of at least 10 pack years * chronic obstructive pulmonary disease at global initiative for chronic obstructive lung disease (gold) stage ii - iv diagnosed according to standard criteria. * history of at least one copd exacerbation requiring systemic corticosteroid treatment or hospitalisation in the previous year exclusion criteria: * insufficient compliance to study medication (≤70% of tablets used) during 4 weeks run-in period * history of acute exacerbation 4 weeks prior to run-in period * diagnosis of alpha-1-antitrypsin deficiency * diagnosis of asthma * acute respiratory infections (e.g. pneumonia) * severe acute infectious diseases (e.g. active hepatitis, hiv) * lung cancer * bronchiectasis * interstitial lung disease * any other relevant lung disease * acute myocardial infarction * systolic left ventricular dysfunction * congestive heart failure new york heart association functional classification (nyha) severity grade iv * haemodynamically significant cardiac arrhythmias or heart valve deformations * peripheral arterial occlusive disease * acute or chronic renal/hepatic failure * active malignancy * autoimmune disease * pregnant or breastfeeding women * women no using or not willing to use adequate contraceptive measures for the duration of the trial * hypersensitivity to study medication or placebo * severe psychiatric or neurological disorders or history of depression associated with suicidal ideation or behaviour * galactose intolerance, lactase insufficiency or glucose-galactose malabsorption

Keywords: copd comorbidity arterial stiffness roflumilast
oral glibenclamide in preterm infants with hyperglycaemia (galop)

Conditions: Transient; Hypoglycemia, Neonatal; Preterm; Glibenclamide Adverse Reaction

Summary: the purpose of this study is to confirm hypothesis that glibenclamide can be administered orally and is an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.

transient hyperglycemia of premature newborns results from an overall decrease in insulin sensitivity, which is responsible at the beta cell level for abnormalities of intragranular cleavage of proinsulin into insulin, leading to reduced active insulin secretion. intravenous administration of exogenous insulin can be used to combat insulin resistance and lower blood glucose, but it is difficult to manage in premature newborns and is associated with a substantial risk of hypoglycemia. glibenclamide, which stimulates endogenous insulin secretion and can be administered orally, might be an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.

Eligibility criteria:
inclusion criteria: * newborn less than 34 week of amenorrhea corrected age * birth weight \< 1500 g * birth term \< 32 week of amenorrhea * hyperglycemia ≥ 10 mmol/l in 2 measurements, 3 hours apart after potential reduction of glucose intakes following each department's protocol * secure venous access point (umbilical venous catheter or epicutaneo-cava catheter) * enteral feeding considered before inclusion or already established * consent obtained from persons holding parental authority * beneficiary of social security exclusion criteria * contraindication to enteral feeding (at the discretion of the clinician responsible for the child) * contraindication to glibenclamide according to current spc * foetal growth restriction (fgr) birth weight \< 3rd percentile (audipog definition) * severe birth defect, including cardiac malformation associated with a risk of myocardial ischemia * severe sepsis requiring mechanical ventilation or haemodynamic support * severe renal dysfunction (serum creatinine \> 120 µmol/l) * severe hepatocellular failure (v factor less than the standard laboratory range for the age) and/or severe cholestasis (\> 50 µmol/l) * hyperglycemia associated with an error in administering glucose infusion * profound hypophosphoremia (\< 1 mmol/l) * hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipients * patient with continuous insulin iv administration * patient treated with miconazole

Keywords: transient hypoglycemia preterm glibenclamide